Safety evaluation of an extension of use of the food enzyme β-amylase from barley (Hordeum vulgare).

The food enzyme β-amylase (4-α-d-Glucan maltohydrolase, EC 3.2.1.2) is produced from barley (Hordeum vulgare) by Senson Ltd. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in four food manufacturing processes. Subsequently, the applicant requested to extend its use to include two additional processes. In this assessment, EFSA has updated the safety evaluation of this food enzyme when used in a total of six food manufacturing processes. As the food enzyme-total organic solids (TOS) are removed from the final foods in two food manufacturing processes, the dietary exposure to the food enzyme-TOS was estimated for the remaining four processes. It was calculated to be up to 10.22 mg TOS/kg body weight (bw) per day in European populations. This exposure estimate is lower than the exposure to a fraction of barley comparable to the food enzyme-TOS via the consumption of barley-derived foods. Based on the revised dietary exposure and the previous evaluation, the Panel concluded that the food enzyme β-amylase produced from barley does not give rise to safety concerns under the revised conditions of use.